Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1689-2020 — Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.

U.S. FDA — Device Enforcement · United States · 2020-03-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1689-2020
Date of alert: 2020-03-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Bard Peripheral Vascular Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0001303256

Reported risk: Sterility compromised due to packaging pouches that may not be sealed properly

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1689-2020 — Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.

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